Type 2 Diabetes Mellitus (T2DM)Phase 2NCT07055386
A Study to Compare the Efficacy and Safety of GZR102 Injection and GZR18 Injection in Type 2 Diabetes Mellitus
A Phase 2 study testing GZR102 and GZR18 in people with Type 2 Diabetes Mellitus (T2DM), run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This is a multicenter, randomized, open-label, positive controlled efficacy exploration study. To compare the efficacy and safety of once-weekly GZR102 Injection and Bi-Weekly GZR18 Injection in Chinese adult subjects with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on GLP-1 receptor agonists… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- GZR102 and GZR18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2025to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- 2. Males or females aged ≥ 18 years at the time of signing the Informed Consent Form (ICF).
- 3. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of blood pregnancy tests at screening and predose.
- 4. According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.
- 5. No Insulin treatment within one year before the screening. 6. Subjects who have been on a stable dose of GLP-1RA therapy for diabetes mellitus as per the package insert for ≥ 90 days before screening, with or without antidiabetic drugs.
Who cannot join
- 1. Subjects with a history of drug abuse before screening or a history of alcohol abuse within 6 months before screening.
- 2. Subjects with a history of allergy to ≥ 2 drugs, or known or suspected hypersensitivity or intolerance to the IMP or similar products and their excipients.
- 3. Subjects who have taken any concomitant medication, that is known to affect weight or glucose metabolism for more than 14 consecutive days within the 90 days before screening, or who require long-term use during the study.
- 4. Participation in a clinical study of another IMP, surgery, or device within 90 days before screening.
- 5. Severe chronic complications of diabetes at the time of screening. 6. Diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic diabetic coma in the 90 days prior to screening.
- 7. Grade 3 hypoglycemic events within 1 year prior to screening. 8. Subjects with significant hematological disorders in screening; or subjects who have donated bloods (> 400 mL), experienced significant blood loss (> 400 mL) or received a transfusion within 90 days before screening.
Show all 11Show fewer
- 9. Subjects with a history of (acute or chronic) pancreatitis in or before screening.
- 10. Subjects with a history of malignant tumors within 5 years before screening or the presence of potential malignant tumors in screening.
- 11. Subjects with a personal history or first-degree family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- 12. Subjects with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg during screening. 13. History of renal transplant or current renal replacement therapy. 14. Expect significant changes in diet, exercise, working circadian rhythm and other lifestyles during the study that may affect glycemia control, or unwilling to comply with relevant lifestyle restrictions during the study.
- 15. Subjects who are unable to comply with the requirements of this protocol as judged by the investigator, or have any other conditions that the investigator considers inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Study to Compare the Efficacy and Safety of Once-Weekly GZR102 Injection and Bi-weekly GZR18 Injection in Type 2 Diabetes Mellitus With Inadequate Glycemic Control on GLP-1 Receptor Agonists, With or Without Oral Antidiabetic Drugs
This is a multicenter, randomized, open-label, positive controlled efficacy exploration study. To compare the efficacy and safety of once-weekly GZR102 Injection and Bi-Weekly GZR18 Injection in Chinese adult subjects with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on GLP-1 receptor agonists (GLP-1RAs), with or without oral antidiabetic drugs (OADs).
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- GZR102, GZR18
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR102Drug
Administered SC
GZR18Drug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| GZR102 | Experimental | participants will receive GZR102 subcutaneously Receives: Drug: GZR102 |
| GZR18 | Experimental | participants will receive GZR102 subcutaneously Receives: Drug: GZR18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficiency endpoint
Change from baseline in Hemoglobin A1c (HbA1c)%
Measured: Week 24
Secondary outcomes (3)
efficiency endpoint
Change fom baseline in fasting plasma glucose (FPG)
Measured: Week 24
hypoglycemic events.
Percent change (%) from baseline in weight
Measured: Week 24
hypoglycemic events.
Treatment-emergent adverse events (TEAEs)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start7 Aug 2025
- Primary completion28 Jun 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Gan & Lee Pharmaceuticals.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055386
- Sponsor's protocol ID
- GZR102-T2D-201
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Compare the Efficacy and Safety of Once-Weekly GZR102 Injection and Bi-weekly GZR18 Injection in Type 2 Diabetes Mellitus With Inadequate Glycemic Control on GLP-1 Receptor Agonists, With or Without Oral Antidiabetic Drugs
- ClinicalTrials.gov ID
- NCT07055386
- Acronym / sponsor ID
- GZR102-T2D-201
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, open-label, positive controlled efficacy exploration study. To compare the efficacy and safety of once-weekly GZR102 Injection and Bi-Weekly GZR18 Injection in Chinese adult subjects with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on GLP-1 receptor agonists (GLP-1RAs), with or without oral antidiabetic drugs (OADs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR102 | Experimental | Drug: GZR102participants will receive GZR102 subcutaneously |
| GZR18 | Experimental | Drug: GZR18participants will receive GZR102 subcutaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- 2. Males or females aged ≥ 18 years at the time of signing the Informed Consent Form (ICF).
- 3. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of blood pregnancy tests at screening and predose.
- 4. According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.
- 5. No Insulin treatment within one year before the screening. 6. Subjects who have been on a stable dose of GLP-1RA therapy for diabetes mellitus as per the package insert for ≥ 90 days before screening, with or without antidiabetic drugs.
Key exclusion criteria (11 listed)
- 1. Subjects with a history of drug abuse before screening or a history of alcohol abuse within 6 months before screening.
- 2. Subjects with a history of allergy to ≥ 2 drugs, or known or suspected hypersensitivity or intolerance to the IMP or similar products and their excipients.
- 3. Subjects who have taken any concomitant medication, that is known to affect weight or glucose metabolism for more than 14 consecutive days within the 90 days before screening, or who require long-term use during the study.
- 4. Participation in a clinical study of another IMP, surgery, or device within 90 days before screening.
- 5. Severe chronic complications of diabetes at the time of screening. 6. Diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic diabetic coma in the 90 days prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GZR102Administered SC | Drug | GZR102 |
| GZR18Administered SC | Drug | GZR18 |
Primary outcome
efficiency endpoint
Time frame: Week 24
Change from baseline in Hemoglobin A1c (HbA1c)%
3 secondary outcomes
efficiency endpoint
Time frame: Week 24
hypoglycemic events.
Time frame: Week 24
hypoglycemic events.
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GZR102 and GZR18 in people with Type 2 Diabetes Mellitus (T2DM), run by Gan & Lee Pharmaceuticals. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficiency endpoint (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.